EUCTR2018-000539-29-IT进行中（未招募）1 期
PeriOperative ISchemic Evaluation – 3 Trial (POISE-3). - POISE-3
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •o Undergoing noncardiac surgery;
- •o >= 45 years of age;
- •o Expected to require at least an overnight hospital admission after surgery
- •o Provide written informed consent to participate in the POISE-3 Trial, AND
- •o Fulfill >=1 of the following:
- •NT-proBNP >= 200 ng/L
- •History of coronary artery disease
- •History of peripheral arterial disease
- •History of stroke
- •Undergoing major vascular surgery
- •Any 3 of 9 risk criteria
- •o Undergoing major surgery
- •o History of congestive heart failure
- •o History of a transient ischemic attack
- •o Diabetes and currently taking an oral hypoglycemic agent or insulin
- •o Age >= 70 years
- •o History of hypertension
- •o Serum creatinine > 175 µmol/L (> 2.0 mg/dl)
- •o History of smoking within 2 years of surgery
- •o Undergoing emergent/urgent surgery.
- •Patients will be eligible for inclusion in the cogPOISE-3 substudy if they are enrolled in both the TXA and blood pressure management arms of the POISE-3 trial. cogPOISE-3 patients will be included in the cognitive assessment part of the substudy if they consent to the assessment of their cognitive performance at baseline (i.e., within 30 days prior to randomization) and at 1 year after randomization. Patients with a documented history of dementia will not be eligible for the cognitive
- •assessment part of the substudy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 750
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 750
排除标准
- •o Patients undergoing cardiac surgery
- •o Patients undergoing cranial neurosurgery
- •o Planned use of systemic TXA during surgery
- •o Hypersensitivity or known allergy to TXA
- •o Creatinine clearance <30 mL/min (Cockcroft-Gault equation) or on chronic dialysis
- •o Patients undergoing surgery for pheochromocytoma or history of untreated pheochromocytoma,
- •o History of seizure disorder
- •o Patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous
- •thromboembolism (<3 month)
- •o Patients with fibrinolytic conditions following consumption coagulopathy
- •o Patients with subarachnoid hemorrhage within the past 30 days
- •10. Women of childbearing potential who are not taking effective contraception, pregnant or breast-
- •o Previously enrolled in POISE-3 Trial
研究者
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PeriOperative ISchemic Evaluation-3 (POISE-3) TrialThe occurrence of life-threatening, major, and critical organ bleeding, and, major arterial and venous thrombosis in patients undergoing noncardiac surgery. And for patients in the blood pressure management factorial, the occurrence of vascular death and major vascular events.MedDRA version: 20.0Level: LLTClassification code 10043611Term: Thrombosis arterialSystem Organ Class: 100000004866MedDRA version: 21.0Level: LLTClassification code 10043640Term: Thrombosis venousSystem Organ Class: 100000004866MedDRA version: 23.1Level: LLTClassification code 10051014Term: Post procedural bleedingSystem Organ Class: 100000004863EUCTR2018-000539-29-BEHamilton Health Sciences Corporation10,000